Associate Medical Device Consultant
MEDIcept
Brian Siroka is an Associate Consultant in Quality Engineering at MEDIcept. Brian has several years of experience in the medical device industry with an aptitude for risk management and design and development. Brian joined MEDIcept through the Leadership Immersion Program where he gained experience in Clinical Affairs, Regulatory Affairs, Quality Systems, and Quality Engineering. Brian was permanently placed in Quality Engineering.
As an associate consultant in Quality Engineering, Brian is responsible for developing and implementing risk management processes. Brian takes a lifecycle approach to risk management by implementing risk throughout the whole quality management system including design, CAPA, suppliers, etc. Brian also aids in the creation of post market surveillance systems that feed back into the risk management files. Brian also has experience conducting literature reviews and writing design inputs based on risk management outputs. He has a friendly and caring attitude with a hardworking mentality and passion for the field.
Brian holds a dual B.S. degree in Mechanical Engineering and Biomedical Engineering from The Pennsylvania State University. He also holds an AAMI Certificate for Integrating Risk Management into the Product Life Cycle and an NSF ISO13485 Lead Auditor Certification. Brian has presented at multiple conferences, such as RAPS, MEDCON, and Biomedevice, about integrating the risk management lifecycle throughout the quality management system.
Risk Management - Systems Perspective
Thursday, April 24, 2025
2:25 PM – 3:55 PM East Coast USA Time